Clinical Study About the Role of COX-2 Inhibitor in Liver Cirrhosis With Biliary Atresia

NCT02298218 | Completed Phase 4

• 1 other identifier: 4-2008-0597
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this clinical study, meloxicam will be used to the patients who are older than 2 years and underwent Kasai portoenterostomy to treat their biliary atresia before. Before and after the medication, their liver stiffness scores will be checked using hepatic Fibroscan. Liver stiffness scores will be compared before and after the medication of meloxicam, and the roll of the COX-2 inhibitor (meloxicam) in the patients with biliary atresia in releasing their hepatic fibrosis. Also, the side effect of the drug will be checked. The intervention drug, meloxicam is safe medicine which is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old. It may also be used for purposes not listed in the medication guide. It will be taken once a daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group). After 6 months of medication, the maintenance will be decided by the comparison of liver stiffness score before and after the intervention.

Conditions

Biliary Atresia, Kasai Portoenterostomy Status

Outcome Measures

Primary Outcomes (1)

• liver stiffness score on FibroScan

  statistical comparison between liver stiffness score of study group (COX-2 inhibitor group) and control group (no intervention group) before and after the clinical study using t-test, chi-square and logistic regression test)

  from 6 to 12 years

Study Arms (2)

Meloxicam

EXPERIMENTAL

The intervention drug, meloxicam is safe medicine which is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old. It may also be used for purposes not listed in the medication guide. It will be taken once a daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group). After 6 months of medication, the maintenance will be decided by the comparison of liver stiffness score before and after the intervention.

Drug: Meloxicam

No intervention

NO INTERVENTION

During 6 months, without meloxicam, the maintenance will be decided by the comparison of liver stiffness score comparing the intervention group.

Interventions

Meloxicam DRUG

The intervention drug, meloxicam is safe medicine which is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old. It may also be used for purposes not listed in the medication guide. It will be taken once a daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group). After 6 months of medication, the maintenance will be decided by the comparison of liver stiffness score before and after the intervention.

Meloxicam

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients who had undergone a Kasai portoenterostomy for BA, and who were postoperatively managed in our outpatient clinic
• Patients who made informed consent for clinical study of COX-2 inhibitor
• Patients who were followed up with liver fibroscan study
• Patients who were over 2 years old and less than or equal to 17 years

You may not qualify if:

• Patients who were impossible to join the clinical study because of their underlying diseases (renal disease, liver disease, diabetes mellitus, GI disease, including bleeding, perforation, or ulceration, etc.) other than biliary atresia, ii) H. pylori infection, iii) asthma, iv) nasal polyp, v) hypertension, vi) hematologic disease, vii) coagulopathy, viii) cardiac disease, ix) vascular disease
• Patients who did not get the drug (COX-2 inhibitor)
• Patients who did not check liver fibroscan
• Patients who were impossible to join the clinical study because of their complication after Kasai portoenterostomy
• Patients who did not make informed consent for clinical study of COX-2 inhibitor
• Patients who cannot take drug because of their allergy, skin disease or asthma attack to drug (COX-2 inhibitor)
• Patients who were decided to withdraw because of their severe drug adverse events

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Conditions

Biliary Atresia

Interventions

Meloxicam

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Seok Joo Han, MD

  Department of Pediatric Surgery, Severance Children's Hospital, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 21, 2014
• Study Start: September 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 21, 2014

Record last verified: 2014-11